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| Name | Class |
|---|---|
| KCRI | OTHER |
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The aim of the study is to confirm, whether the MER® stent can be used, without limitations, for the endovascular carotid stenosis treatment in daily clinical practice. Eligible patients will undergo the procedure of the common or internal carotid artery stenting using MER® with proximal or distal neuroprotection.
MER® stent will be implanted in eligible patients with common and internal carotid stenosis after an informed consent.
Potential benefit of the MER® stent implantation will be evaluated based on angiography and duplex Doppler ultrasound examination.
Follow ups are scheduled at 30 days, 6 and 12 months after index procedure. Except for clinical follow up patients will undergo carotid vessels ultrasound examination after 6 and 12 months. In case of an emergency visit, caused by the Serious Adverse Event, Patient will undergo: neurological and cardiac evaluation as well as carotid vessels USG examination and extended CT or MRI scans.
In general, all procedures in the study will follow the local standard of care. The type of devices used during the angioplasty (including the MER® stents) will not differ from the devices used in the usual clinical practice in the hospital. DAPT and other medical therapy will be consistent with the rules of the Polish and European Society of Cardiology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with MER stent | Experimental | Patients eligible for Carotid Artery Stenting |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MER | Device | carotid artery stenting |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stroke within 30 days after the procedure | Stroke within 30 days after the procedure | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| MAE | compound Major Adverse Events (death, stroke, heart attack) within 30 days after the procedure | 30 days |
| MAE | compound Major Adverse Events (death, stroke, heart attack) within 365 days after the procedure. Restenosis (%DS ≥50%) within 365 days. |
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Inclusion Criteria:
De novo lesion located in the internal carotid artery or common carotid artery
Target lesion available for 20-60mm lenght and 4-10mm diameter scaffold
Patient eligible for CAS
Age ≥ 18
Life expentancy ≥ 12 months
The patient's written informed consent has been obtained prior to the procedure.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Piotr Odrowąż-Pieniążek, Prof. | Oddział Kliniczny Chorób Serca i Naczyń Krakowski Szpital Specjalistyczny im. Jana Pawła II ul. Prądnicka 80 31-202 Kraków | Principal Investigator |
| Paweł Buszman, Prof. | I Oddział Kardiologiczno-Angiologiczny American Heart of Poland S.A. ul. Sanatoryjna 1 43-450 Ustroń | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Małopolskie Centrum Sercowo-Naczyniowe PAKS American Heart of Poland S.A., Oddział Chirurgii naczyniowej | Chrzanów | 32-500 | Poland | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24799929 | Background | Maciejewski D, Pieniazek P, Tekieli L, Paluszek P, Dzierwa K, Trystula M, Wojcik-Pedziwiatr M, Podolec P. Transradial approach for carotid artery stenting in a patient with severe peripheral arterial disease. Postepy Kardiol Interwencyjnej. 2014;10(1):47-9. doi: 10.5114/pwki.2014.41469. Epub 2014 Mar 23. | |
| 23825008 | Background |
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| ID | Term |
|---|---|
| D016893 | Carotid Stenosis |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 365 days |
| Target vessel revascularization within 365 days | Target vessel revascularization within 365 days | 365 days |
| Procedure success | Procedure success (with residual stenosis ≤30%) | 365 days |
| SADE | Serious Adverse Device Effect | 365 days |
| Górnośląskie Centrum Medyczne im. prof. Leszka Gieca Uniwersytetu Medycznego w Katowicach, Oddział Chirurgii Ogólnej, Naczyń, Angiologii i Flebologii |
| Katowice |
| 40-635 |
| Poland |
| Oddział Kliniczny Chorób Serca i Naczyń Krakowski Szpital Specjalistyczny im. Jana Pawła II | Krakow | 31-202 | Poland |
| Centrum Interwencyjnego Leczenia Udaru i Chorób Naczyniowych Mózgu Instytut Psychiatrii i Neurologii | Warsaw | 02-957 | Poland |
| Dzierwa K, Pieniazek P, Tekieli L, Musialek P, Przewlocki T, Kablak-Ziembicka A, Kosobucka-Peszat R, Machnik R, Trystula M, Podolec P. Carotid artery stenting according to the "tailored CAS" algorithm performed in the very elderly patients: the thirty day outcome. Catheter Cardiovasc Interv. 2013 Nov 1;82(5):681-8. doi: 10.1002/ccd.25025. Epub 2013 Jul 3. |
| 22528713 | Background | Pieniazek P, Tekieli L, Musialek P, Kablak Ziembicka A, Przewlocki T, Motyl R, Dzierwa K, Paluszek P, Hlawaty M, Zmudka K, Podolec P. Carotid artery stenting according to the tailored-CAS algorithm is associated with a low complication rate at 30 days: data from the TARGET-CAS study. Kardiol Pol. 2012;70(4):378-86. |
| 22293887 | Background | Musialek P, Pieniazek P, Tracz W, Tekieli L, Przewlocki T, Kablak-Ziembicka A, Motyl R, Moczulski Z, Stepniewski J, Trystula M, Zajdel W, Roslawiecka A, Zmudka K, Podolec P. Safety of embolic protection device-assisted and unprotected intravascular ultrasound in evaluating carotid artery atherosclerotic lesions. Med Sci Monit. 2012 Feb;18(2):MT7-18. doi: 10.12659/msm.882452. |
| 21804476 | Background | Dzierwa K, Pieniazek P, Musialek P, Piatek J, Tekieli L, Podolec P, Drwila R, Hlawaty M, Trystula M, Motyl R, Sadowski J. Treatment strategies in severe symptomatic carotid and coronary artery disease. Med Sci Monit. 2011 Aug;17(8):RA191-197. doi: 10.12659/msm.881896. |
| 20859914 | Background | Pieniazek P. [A new era for the stenting of the carotid arteries in the light of the CREST study]. Kardiol Pol. 2010 Sep;68(9):1086-7. No abstract available. Polish. |
| D009422 | Nervous System Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |